Orthotic protective device

ABSTRACT

An orthotic protective device collectively including a base unit connected to a metacarpal unit by a hinge system designed to protect and prevent hyperextension and hyperflexion movements of the metacarpal, carpal, radius and ulna regions. The base unit and metacarpal unit includes a longitudinal support member and a casing, respectively, lined with at least one pad having a tongue. At least one releasable fastener is mated to the support member and casing and extends to the tongue of the pad. 
     Apertures of the base unit are mated and connected to apertures of the hinge system which form an articulated joint allowing the hinge system to move in an upward manner allowing for natural extension of the user&#39;s wrist and in a downward fashion for unlimited flexion motion. The base unit and the hinge system may both have at least one stop formed thereon; and as these stops come into contact with one another, it limits the flexion, extension and radial-ulnar deviation. Further, an aperture of the metacarpal unit is mated and fastened to an aperture in the hinge system by a swivel joint which allows for lateral movement of the user&#39;s wrist.

PRIOR APPLICATIONS

This application claims the benefit of Provisional Patent ApplicationSer. No. 60/395,801 filed on Jul. 16, 2002.

This application is a continuation of Ser. No. 10/623,271 filed Jul. 15,2003, now U.S. Pat. No. 7,402,148.

TECHNICAL FIELD

The present invention relates generally to an orthotic protectivedevice, more particularly a brace for the metacarpals, carpals, radiusand ulna regions and method of providing the same which provides fornormal movement of a user.

BACKGROUND OF THE INVENTION

A wide range of activities such as playing a musical instrument, playinggolf, opening a bottled drink or even laying bricks are all impossibleactivities to execute without the health of a user's arm, wrist andhands. Nevertheless, these physiological areas are most prone to injuryin the human body.

Today, a number of physical therapists and physicians deal with twomajor types of injuries: (1) repetitive motion injuries and (2)traumatic injuries. The repetitive motion injuries develop over a periodof time where consistent use of the arms, wrists and hands are required,such as assembly line tasks. Such repetitive motion injuries are treatedby developing plans to address muscle and joint stress and weakness andredesigning workstations, tools and equipment.

However, traumatic injuries such as fractures and lacerations requireimmediate medical care. One type of traumatic injury is a sprain whichcan take weeks to heal properly. A physician or therapist focuses onrestoring strength and mobility and on preventing the creation ofadverse scar tissue which can permanently affect the function of thehand, wrist or any joint.

Another type of traumatic injury is the result of sporting accidents,such as inline skating accidents. Here, if a sporting enthusiast fallson his/her outstretched hand, the enthusiast may suffer a Colles'fracture, a fracture of the bones of the forearm (the radius and theulna) near the wrist (or carpal bones). In order to prevent such aninjury from occurring, the enthusiast should wear protective gearincluding wrist protectors.

Examples of such a device is depicted in U.S. Pat. No. 6,165,148(hereinafter called '148) issued to Carr-Stock on Dec. 26, 2000. The'148 patent provides for a wrist/hand/finger orthosis having a splintmember extending from forearm to fingertips, a cover enclosing thesplint member and a plurality of releasable straps connected to thecover.

An advancement in the orthotic industry was to combine elastic andnon-elastic fabric in the construction of wrist braces. An example of adevice incorporating these fabrics is depicted in U.S. Pat. No.6,186,969 (hereinafter called '969) issued to Bell on Feb. 13, 2001. The'969 patent is a wrist brace having a sheet of flexible material havinga first portion which is substantially non-stretchable and a secondportion which is stretchable. The first and second portions allow thebrace to vary the compression on the proximal portion of the wrist whichis sought to be immobilized.

Protection aids for hands and wrists have continued to develop as isevident with U.S. Pat. No. 6,279,159 (hereinafter called '159) issued toAhlbaumer on Aug. 28, 2001. The '159 patent describes a hand and wristprotective aid comprising a first protective element to be arranged onthe region of the hand palm situated near the wrist. A second protectiveelement is arranged on the inside portion of the wrist and is connectedto the first protective element via a connecting element. However, theforearm of a user is left exposed and unprotected.

In 2003, a wrist brace was designed to fixedly link a user's hand to auser's forearm in a rigid fashion whereby the wrist is held in arelatively neutral position as seen in U.S. Pat. No. 6,540,710 issued toCruz on Apr. 1, 2003. The '710 patent provides for a brace, namely aone-piece unit designed to fit on top of the hand and forearm.

Aside from the physical structure of the brace, other developments haveinvolved the evolution of the materials. An example of this enhancedmaterial is taught in U.S. Pat. No. 6,080,121 (hereinafter called '121)issued to Madow on Jun. 27, 2000. The '121 patent describes a laminatedorthopedic brace made of a unique blend of material combining Airprene™with Coolmax™ material as a liner. This material blend allowed forbreathability, compression and heat retention.

SUMMARY OF THE INVENTION

The present invention in its several disclosed embodiments alleviatesthe drawbacks described above with respect to orthotic devices andincorporates several additionally beneficial features. The presentinvention described herein is an orthotic protective device, namely abrace to protect and prevent hyperextension and hyperflexion movementsof the metacarpal, carpal, radius and ulna regions. The orthoticprotective device generally includes a hinge system located between abase unit and a metacarpal unit. The base unit includes a longitudinalsupport member and the metacarpal unit includes a casing. Each unit islined with at least one pad having a tongue. At least one releasablefastener is mated to the support member and casing and extends to thetongue of the pad. The tongue of the pad which is connected to thecasing has a digit opening to accommodate the digit and is connected toan attachment means.

Apertures of the base unit are mated and connected to apertures of thehinge system which form an articulated joint allowing the hinge systemto move in an upward manner allowing for natural extension of the user'swrist and in a downward fashion for unlimited flexion motion. The baseunit and the hinge system may both have at least one stop formedthereon; and as these stops come into contact with one another, itlimits the flexion, extension and radial-ulnar deviation. Further, anaperture of the metacarpal unit is mated and fastened to an aperture inthe hinge system by a swivel joint which allows for lateral movement ofthe user's wrist.

Another benefit of the present invention is for each pad, such as thesupport pad(s), interior pad and internal pad, may include coolingand/or heating coils embedded within each pad to either provide the usera cooling or heated effect to reduce swelling and provide relief.

It is therefore a goal of the present invention to provide an orthoticprotective device designed to prevent and treat injuries namely for thecarpal joint, but also for the metacarpal bones, radius and ulnaregions. The orthotic protective device permits normal flexion andextension of the carpal joint while simultaneously preventinginvoluntary hyper-flexion and hyperextension of this joint.

Another advantage of the present invention is to provide the orthoticdevice to be worn prophylactically to protect the carpal joint and itssurrounding areas from external contact such as blows and impact injury,including but not limited to bodily, equipment or object impact.Further, the orthotic device is easy to manufacture and may be utilizedfor both personal and commercial uses.

Additionally, the support member may be formed as a one-piece unit or asa segmented body allowing physiological options for the user. Thesupport member may be made of various materials such as thermoplasticmaterial which may be mass produced or customized to fit a particularindividual.

Further advantages of the invention will be more clearly understood fromthe following description of illustrative embodiments thereof, to beread by way of example and not of limitation in conjunction with theapparatus and method shown. The beneficial effects described above applygenerally to exemplary devices disclosed herein of the orthoticprotective device. The specific structures through which these benefitsare delivered will be described in detail herein below.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in greater detail in the followingway of example only and with reference to the attached drawings, inwhich:

FIG. 1 is a top plan view of an orthotic protective device having ahinge system allowing for movement of a patient's wrist.

FIG. 2 is a bottom plan view showing an interior surface of the presentinvention.

FIG. 3 is a plan view of the present invention depicting the device wornon a user and extending from the forearm to the hand.

FIG. 4 is a bottom view of the present invention.

FIG. 5 is a left side view of the present invention.

FIG. 6 is a right side view of the present invention.

FIG. 7 is a top plan view of the present invention depicting the lateralswivel capabilities of the hinge system.

FIG. 8 is a side view of the present invention depicting the user'swrist extending from a horizontal position to a normal flexion position.

MODE(S) FOR CARRYING OUT THE INVENTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention that may be embodied in variousand alternative forms. The figures are not necessarily to scale, somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as abasis for the claims and as a representative basis for teaching oneskilled in the art to variously employ the present invention. Althoughthose of ordinary skill in the art will readily recognize manyalternative embodiments, especially in light of the illustrationsprovided herein, this detailed description is exemplary of the preferredembodiment of the present invention, the scope of which is limited onlyby the claims appended hereto.

Anatomy of the Hand, Wrist and Forearm

The elbow is a hinge joint connecting the upper arm bone (humerus) withthe bones of the forearm (the radius and the ulna). Specifically, theelbow consists of three joints enclosed within a capsule and heldtogether by muscles, tendons, and ligaments. Tendons are fibrous cordsthat attach muscles to bones; and ligaments are bandage-like sheaths offibrous tissues that attach bones to bones and keep the joints and bonesin alignment.

Unlike the elbow, the wrist and hand are more complex in structure.There are eight wrist bones known as carpals which support the carpaltunnel which contains tendons and the median nerve and is covered by atransverse carpal ligament.

In the hand, the metacarpal bones form the structure of the hand itselfand are connected to the finger bones (the phalanges). There are threephalanges in each finger and each finger is supplied with two types oftendons: an extensor tendon on top, which straightens the finger, and aflexor tendon on the bottom, which bends the finger. Interphalangealjoints are the joints between different sections of the finger andmetacarpal phalangeal joints connect the fingers to the hand.

The Invention

FIGS. 1-8 illustrate an orthotic protective device 5, namely a brace toprotect and prevent hyperextension and hyperflexion movements of themetacarpal, carpal, radius and ulna regions and provide normal pitch andyaw movements of a user. The orthotic protective device 5 collectivelyincludes a hinge system 20 positioned between a base unit 10 and ametacarpal unit (also known as the hand unit) 30.

FIGS. 1 and 2 show the base unit 10 incorporates a substantially rigid,elongated support member 11 including an interior surface 59 and anexterior surface 57 having a distal end 50, a middle region 53 and aproximate end 55. The elongated support member 11 is preferably shapedas an inverted “U” capable of being positioned on a dorsal side of theradius-ulna region of the user and substantially surrounds and conformsto the user's forearm to ensure a secure fit as seen in FIGS. 3 and 4.Here, the support member 11 may either be formed as a one-piece unit; oralternatively, as a segmented body where each segment is joined to oneanother to adapt to the user's specific body specifications. The supportmember 11 may be made of, but not limited to, such materials as moldablecarbon fiber, epoxy matrix carbon fiber, KEVLAR™ (aramid fiber)composite material, hard plastic or thermoplastic material which may bemass produced as an off-the-shelf item or customized to fit a particularindividual.

FIG. 2 shows the interior surface 59 of the elongated support member 11is lined with at least one or more support pad(s) 12 attached therein.The support pad(s) 12 and internal pad 35 may be fastened to theinterior surface 59 by, but not limited to, hook and loop material suchas Velcro™, adhesive, pins, screws, buttons and the like. The supportpad(s) 12 may contour a substantial portion or entire surface area ofthe interior surface 59. In the most preferred embodiment, the supportpad 12 has a tongue which projects beyond the surface area of theinterior surface 59 and is designed to extend around the volar surfaceof the radius-ulna region.

At least one releasable fastener 14 is coupled to the exterior surface57 of the elongated support member 11, preferably on the middle region,53 as depicted in FIGS. 3, 5 and 6. The releasable fastener 15,preferably a strap, may be fastened to the exterior surface 57 by, butnot limited to, Velcro™, adhesive, pins, screws, buttons, nuts, boltsand the like. Specifically, a first end of the releasable fastener 15 ismounted, preferably to a hook and loop patch 14 adhered onto theexterior surface 57 of the support member 11. A second end of thereleasable fastener 15 orthogonally extends from the exterior surface 57and is attached to the tongue of the support pad 12.

The middle region 53 of the exterior surface 57 is adjacently positionedto the proximate end 55 and is positioned across the radius-ulna region.Desirably, the proximate end 55 may be asymmetrically configured toimpart comfort and prevent a feeling of confinement to the user. Thedistal end 50 is also located adjacent to the middle region 53 and isnear and extends across the carpal region.

The distal end 50 has opposing sides 70, 72, where each side includes anaperture 16 bored through the support member 11 and capable of receivingconnectors 90 therein. Each aperture 16 has a reinforcementperpendicularly extending therefrom designed to surround and support theconnectors 90 inserted through the apertures 16.

The hinge system 20 comprises a shell 21 having polar extended sides 22,23 and a lip 24. An interior pad 35 is removably attached underneath thepolar extended sides 22, 23 thereby providing comfort to the carpalregion of the user. Each polar extended side 22, 23 has an aperture 28capable of accepting fasteners therein. These apertures 28 directlycorrespond to and are positioned underneath the apertures 16 of thesupport member 11 in order to accept the inserted connectors 90.

The connected apertures 16, 28 form an articulated joint allowing thehinge system 20 to move at about a 45° angle in an upward verticalmanner or until the hinge system 20 abuts the base unit 10, therebylimiting the extension of the carpal area specific to the user's maximumrange of motion as seen in FIG. 7. FIG. 8 depicts the articulated jointhaving no flexion resistance.

Operatively speaking, the joint may be flexed at about a 150° angle in adownward manner only limited by the user's natural range of motion. Inan alternative embodiment, the angle of the articulated joint may beseverely limited by incorporating stops 120 on both the shell 21 and thesupport member 11 to limit extension, flexion and ulnar-radialdeviation. As each stop abuts one another, the range of motion isinhibited.

The orthotic protective device 5 undergoes a scanning and moldingprocess, namely by first scanning and measuring a user's physiologicalspecifications; and then translating the measurements into a mold. Themold is then fabricated by utilizing a wet lay-up process using acombination of epoxy resin, carbon fiber and KEVLAR™ (aramid fiber)composite materials. This process allows for normal movement of thecarpal region. The resulting protective device 5 is designed to limitboth extension and flexion of the carpal region specific to thepatient's maximum range of motion. Further, during the scanning, moldingand fabrication process, the stops 120 are formed onto the shell 21 andthe support member 11 thereby limiting the user's movement, both naturaland hyperextended/hyperflexed movements, as shown in FIG. 8.

The lip 24 has an aperture 28 designed to receive a swivel joint 95 orother connector. The aperture 28 preferably has a reinforcementorthogonally projecting therefrom and surrounding the swivel joint 95 oralternate connector.

The metacarpal unit 30 incorporates a casing 31 including an internalsurface 50, and an external surface 51 having an anterior end 52 and aposterior end 54. An internal pad 35 has a tongue 100 and is removablyconnected to the internal surface 50 of the casing 31, preferably by ahook and loop means. Here, either a hook or loop patch is fastened tothe internal surface 50 and is adapted to accept the internal pad 35 asthe loop or hook, respectively, are mated. The internal pad 35substantially conforms to the surface area of the internal surface 50and the tongue 100 projects outwardly and is designed to extend aroundthe volar surface of the user's palm. The tongue 100 has a digit, namelya thumb, orifice 110 allowing the digit to be inserted therethrough.

A first end of an attachment means 32, namely a strap, is fastened tothe casing 31, preferably by a hook and loop connector being adhered tothe external surface 51 of the casing 31. The attachment means 32 hasthe corresponding loop or hook patch, respectively, used to join to theformer patch. A second end extends transversely across the externalsurface and orthogonally extends from the external surface 51 of thecasing 31 and is attached to the tongue 100 of the internal pad 35.

Each pad, namely the support pad(s) 12, interior pad 26 and internal pad35 are resistently compressible, high surface-friction pads designed tosecure the orthotic protective device 5 to the user. The pads 12, 26 and35 may be made from such materials as, but not limited to, open cellfoam, closed cell foam, viscoelastic polymer-gel, cotton, liquidmaterial, granular material or air material. In the most preferredembodiment, each pad 12, 26, 35 may include cooling and/or heating coils42 embedded within each pad 12, 26, 35 to either provide the user acooling or heated effect to reduce swelling and provide relief. Thesecoils 42 are electrically connected to a temperature control means 40which may be manipulated by the user to produce a desired effect.

The posterior end of the casing 31 has an aperture 58 which correspondsto the aperture 28 located on the lip 24 of the shell 21. The swiveljoint 95 or other connector is accepted by both apertures 28, 58 alikeand provides for the metacarpal unit 30 to move in a lateral fashionwith respect to the hinge system 20. Specifically, the swivel joint 95allows up to a 60° turn on each side of its horizontal axis providingfor normal movement of the carpal region. In a preferred embodiment, theswivel joint 95, as well as the connectors 90 may comprise of quickrelease pins allowing for each addition or subtraction of either thebase unit 10, metacarpal unit 30 or other accessory or accessoriesadapted to fit thereto. The substantially rigid casing 31 is preferablypositioned over the dorsal surface of the user's hand, and thesubstantially rigid shell 21 is similarly positioned over the topsurface of the user's forearm, as shown in the figures. Further, in apreferred embodiment, the casing 31 and the shell 21 may be made of suchmaterials as, but not limited to, moldable carbon fiber, epoxy matrixcarbon fiber, KEVLAR™ (aramid fiber) composite material, hard plastic orthermoplastic material which either being mass produced or having a morecustomized fit for an individual.

While the foregoing description is exemplary of the preferred embodimentof the present invention, those of ordinary skill in the relevant artswill recognize the many variations, alterations, modifications,substitutions and the like as are readily possible, especially in lightof this description, the accompanying drawings and claims drawn thereto.Therefore, the foregoing detailed description should not be construed asa limitation of the scope of the present invention, which is limitedonly by the claims appended hereto. The invention is, therefore, claimedin any of its forms or modifications within the proper scope of theappended claims appropriately interpreted in accordance with thedoctrine of equivalents.

INDUSTRIAL APPLICABILITY

The present invention finds specific industrial applicability in themedical and athletic industries.

1. An orthotic device to be worn by a user, comprising: a base unitincluding a support member conforming substantially about a forearm ofthe user, and a support pad on the support member; a metacarpal unitincluding a casing and a metacarpal pad on said casing the metacarpalunit for positioning on the dorsal surface of the user's hand; a hingesystem including a shell extending between the base unit and themetacarpal unit, and a pair of vertical pivot connectors for movablyconnecting the shell to the base unit when worn by the user, such thatthe shell pivots vertically about the pair of connectors in a firstdirection relative to the base unit when worn by the user, the hingesystem further including a lateral connector for movably connecting themetacarpal unit to the shell when worn by the user, such that themetacarpal unit pivots with respect to the shell laterally about thelateral connection in a second direction substantially transverse to thefirst direction when worn by the user, and wherein said support memberand said shell each have at least one stop formed thereon, wherein eachof said stop abuts one another to limit vertical movement of the supportmember relative to said shell.
 2. The orthotic device as recited inclaim 1, wherein said support member, said shell and said casing areeach made of a material selected from the group consisting of epoxymatrix carbon fiber, moldable carbon fiber, aramid fiber compositematerial, plastic and thermoplastic material.
 3. The orthotic device asrecited in claim 1, wherein said support pad, and said metacarpal padbeing made of a material selected from a group consisting of open cellfoam, closed cell foam, cotton, a viscoelastic polymer-gel and an airfilled member.
 4. The orthotic device as recited in claim 3, whereinsaid support pad is detachably affixed on said support member, saidmetacarpal pad is detachably affixed on said casing, and said metacarpalpad is detachably fastened on said shell.
 5. The orthotic device asrecited in claim 1, wherein said metacarpal pad removably positioned onsaid shell.
 6. The orthotic device as recited in claim 1, wherein saidhinge system is capable of moving said shell to a 45° angle in avertical extension fashion with respect to the base unit.
 7. Theorthotic device as recited in claim 1, wherein said hinge system iscapable of moving said shell to a 150° angle in a vertical, flexingfashion with respect to the base unit.
 8. An orthotic device forrehabilitation of a user's wrist, comprising: a base unit having asupport member conforming substantially to a forearm of the user; ametacarpal unit including a casing and a pad and a casing retainer underthe dorsal surface of the user's hand for retaining the casing on thedorsal surface of the hand when worn by the user; a hinge system movablyconnecting the metacarpal unit to the base unit when worn by the user,such that the metacarpal unit pivots vertically in a first directionrelative to the base unit when worn by the user, and the hinge systemfurther movably connecting the metacarpal unit to the base unit whenworn by the user, such that the metacarpal unit pivots laterally withrespect to the base unit in a second direction substantially transverseto the first direction when worn by the user; and said support memberhas at least one stop thereon to limit movement of the metacarpal unitrelative to the base unit.
 9. The orthotic device as recited in claim 8,further comprising: a support pad on said support member, the supportpad being made of a material selected from a group consisting of opencell foam, closed cell foam, cotton, a viscoelastic polymer-gel and anair filled member.
 10. The orthotic device as recited in claim 8,wherein said support member includes a plurality of apertures each forreceiving a vertical connector therein.
 11. The orthotic device asrecited in claim 8, wherein said support member and said casing are eachmade of a material selected from a group consisting of epoxy matrixcarbon fiber, moldable carbon fiber, aramid fiber composite material,plastic and thermoplastic material.
 12. The orthotic device as recitedin claim 8, wherein the hinge system includes a pair of verticalconnectors for pivoting the metacarpal unit in the first direction, anda lateral connector for moving the metacarpal unit in the lateraldirection.
 13. The orthotic device as recited in claim 8, wherein thehinge system further includes a shell extending between the base unitand the metacarpal unit.
 14. The orthotic device as recited in claim 8,wherein said hinge system is capable of moving said metacarpal unit to a45° angle in a vertical extension fashion with respect to the base unit.15. The orthotic device as recited in claim 8, wherein said hinge systemis capable of moving said metacarpal unit to a 150° angle in a vertical,flexing fashion with respect to the base unit.
 16. An orthotic device tobe worn by a user, comprising: a base unit having a support memberconforming substantially to a forearm of the user; a metacarpal unitincluding a casing for positioning on the dorsal surface of the user'shand; and a hinge system connecting said base unit to said metacarpalunit, said hinge system having a shell extending between the base unitand the metacarpal unit, such that the shell pivots vertically in afirst direction relative to the base unit when worn by the user, and thehinge system further including a lateral connector for movablyconnecting the metacarpal unit to the shell when worn by the user, suchthat the metacarpal unit pivots with respect to the shell laterally in asecond direction substantially transverse to the first direction whenworn by the user, said hinge system being capable of moving said shellto a 45° angle in a vertical extension fashion with respect to the baseunit, and to a 150° angle in a vertical, flexing fashion with respect tothe base unit.
 17. The orthotic device as recited in claim 16, furthercomprising: a support pad on said support member, a fastener extendingbetween said support member and said support pad, and a plurality ofapertures in said support member each capable of receiving a verticalconnector therein.
 18. The orthotic device as recited in claim 16,wherein said support member and said shell each has at least one stopformed thereon to limit extension of the metacarpal unit relative to thebase unit.
 19. The orthotic device as recited in claim 16, wherein thehinge system includes a pair of vertical connectors for movablyconnecting the shell to the base unit when worn by the user; and alateral connector for moveably connecting the metacarpal unit to theshell when worn by the user.